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Fall 2014 Orthopaedic Catalogue Specialty Grafting Solutions and accessories... Raptos Bone Granules Orthopaedic Spine Reconstructive Allografts Sports Medicine Trauma Plastic & Reconstructive Demineralized Bone Matrix Synthetic Grafts OR Equipment Citagenix; cita — from the latin citatus meaning “ quick and speedy ”, gen — refers to “ regeneration ”, X — denotes “ expertise ”. Citagenix has teamed up with world leading companies to be able to offer you cutting edge musculoskeletal grafting technologies. DynaGraft II is a well known and trusted osteoinductive DBM graft that was the first DBM product approved as a medical device in Canada. OrthoBlast II combines both osteoinductive and osteoconductive elements. Accell Connexus is Canada’s only DBM which features the Accell technology that increases the bioavailability of BMP’s and other bone derived growth factors to optimize osteoinductive potential. Raptos is our complete line of allograft options. Not only do we provide freeze-dried cancellous bone as a natural scaffold for bone repair, we also supply frozen sports allografts, traditional allografts and bone segments designed for use in the spine. Biomatlante researchers have invested over 20 years in the development of synthetic options. The key to success with engineered products is to control the balance between graft resorption and bone regeneration. MBCP provides this balance, both in particulate form as well as with the new MacroFix cement. Whether you’re repairing an ACL, filling a boney defect, or planning a revision, doing it right depends on being able to easily source the essential grafts and technology. Citagenix is the partner you can depend on to safely and consistently provide tissue and devices. We are the experts you can trust to serve as a knowledgeable resource on the latest innovations; a hands-on partner who provides personalized service and helps you achieve the outcomes you want by understanding the subtleties of your unique practice and surgical techniques. For a trusted and proven partner like this, there is only Citagenix. When it comes to bone and tissue regeneration, our knowledge and experience in the medical device industry is unmatched, giving Canadian health care providers one convenient place to turn to for dependable access to the widest variety of existing and emerging products. We attend shows globally, searching the world for the best products and staying current on the latest tissue repair innovations. We offer over six types of off-theshelf bone grafts and even more options for structural allografts. For knee reconstruction, we offer our « Surgeon Select » service to store a surgeon’s particular choice for sports allografts in Canada. We’re also experts at timely delivery, with next-day service to the large majority of our Canadian customers. Table of contents Raptos Bone Granules Citagenix has partnered with several USA and Canadian based AATB accredited tissue banks to bring you Raptos Allograft ensuring your graft is available when needed in a variety of sizes and configurations. All of the tissue banks that we partner with are also registered with Health Canada as required under the Safety of Human Cells, Tissues and Organs Regulations (CTO Regulations). reCONSTRUCTIVE ALLOGRAFTS Like Raptos particulate, Citagenix has available a wide range of struts, rings and blocks to facilitate skeletal repairs. Sports Medicine With Citagenix’s « Surgeon Select » program, sports allografts can be stored in our Canadian freezers, thus ensuring both the surgeons choice of graft, and overnight delivery. Talk to your local representative for details. Demineralized Bone Matrix Citagenix has teamed up with companies like Integra LifeSciences to offer you cutting edge DBM solutions. With a wide selection of DBM configurations, Citagenix offers powerful choices in DBMs 2&3 4,5 & 6 7 8&9 Synthetic grafts Using the mineral building blocks naturally found in human bone, MBCP and MacroFix go a step beyond the realm of everyday hydroxyapatite (HA) and tricalcium phosphate (TCP) with their unique combination of both micro and macroporosity technology. By maximizing the ratio between these porosities and the balance between HA and TCP, MBCP and MacroFix are the key to controlled bone regeneration. 10, 13 or EQUIPMENT The Citagenix line of OR accessories is continuously growing. These products add value by eliminating OR time or simply by making a procedure easier. Whether the objective is to grind locally harvested bone to particles or to create a bloodless field in seconds, Citagenix has a solution. 14,17 A Canadian company serving Canadian surgeons since 1997 Raptos bone granule products All the cancellous chips you need... under one wing! Raptos allograft cancellous irradiated bone granules are a natural scaffold for bone regeneration. RAPTOS allograft bone offers an osteoconductive platform for bone regeneration. Used either alone or as part of a composite bone graft, allograft bone supplies a natural framework facilitating the attachment of osteogenic precursor cells. Features: Safety information Each donor is thoroughly evaluated using medical/social history questions, medical records, blood tests, culture results, physical examination and autopsy reports (when performed). This process is used to ensure the donor is suitable for donation by allowing to recognize and exclude potential diseases or medical conditions that are unacceptable. Specific lab tests are performed for Syphilis, Hepatitis B and C, HIV and other viruses. All of the donor chart information is evaluated by individuals trained in tissue banking, prior to the processing of the tissue. Tissue grafts are rinsed and soaked in various solutions to minimize transmission of bacteria and viruses. Processing and packaging of the tissue are performed using aseptic technique and occur in a clean room. As an added margin of safety, a low dose gamma irradiation after final packaging of the musculoskeletal grafts is utilized. 2 • Rigorous donor screening, serological testing and formal processing • Low dose gamma irradiation • AATB accredited source • Mandatory CTO registered with Health Canada Cancellous Coarse Cancellous Crushed Cancellous Crushed Fine Raptos Bone Granules Size Cancellous Crushed Fine Cancellous Crushed Cancellous Coarse 5 cc 10 cc 15 cc 30 cc 60 cc 90 cc 1-4 mm CRFINE05 CRFINE10 CRFINE15 CRFINE30 CRFINE60 CRFINE90 1-10 mm CRUSHED05 CRUSHED10 CRUSHED15 CRUSHED30 CRUSHED60 CRUSHED90 4-10 mm COARSE05 COARSE10 COARSE15 COARSE30 COARSE60 COARSE90 All our granules are available free ze dried or frozen Description Cancellous Cubes Cubes Cubes Cubes Cubes Cubes Cubes Size Preservation 5 cc 7.5 cc 15 cc 30 cc 60 cc 90 cc Freeze dried Freeze dried Freeze dried Freeze dried Freeze dried Freeze dried Description Size Cancellous | Cortical Crushed Fine 80|20 Blend 15 cc 80|20 Blend 30 cc 80|20 Blend 60 cc 80|20 Blend 90 cc Orthopaedic Preservation Freeze dried Freeze dried Freeze dried Freeze dried Spine Product code 1198-12 1199-12 1201-12 1023-12 1203-12 1204-12 Product code 1242-12 1243-12 1245-12 1246-12 Trauma 1 877-243-6724 ✦ Citagenix.com 3 Reconstructive Allografts Description Size/Side Product code FD FR Acetabulum Specify Side (L,R) 1196- Cloward Dowel 14 CD-14 Cloward Dowel, Patellar 1022- 12 14 Cortical Disc, Tibia 1022- 12 Cortical Strut, Tibia COR-STRUT Fascia 01-024 cm2 1128- 12 Fascia 25-049 cm2 1129- 12 Fascia 50-100 cm2 1130- 12 Fascia 101-150 cm2 1131- 12 Fascia 151-200 cm2 1132- 12 Fascia 201-250 cm2 1133- 12 Femoral Head w/o Cartilage Femur Distal FEMORAL Length < 11 cm F-SHAFT Femur Shaft Length ≥ 11 cm 1135- 12 14 Femur Shaft, Split (1) 1137- 12 14 Femur, Distal Specify Side (L,R) 1139- 14 Femur, Prox. w/o Head Specify Side (L,R) 1140- 14 Femur, Prox. with Head Specify Side (L,R) 1141- 14 Femur, Ring 1142- 12 14 Femur, Whole Specify Side (L,R) 1143- 14 Femur, Whole w/o Head Specify Side (L,R) 1138- 14 FD= Freeze Dried / FR= Frozen 4 T2 T1 Femur Shaft Orthopaedic Cloward Dowel Spine Trauma 1 877-243-6724 T1 Femur Proximal with Head Reconstructive Allografts Description Size/Side Product code FD FR 114414 114514 1146- 12 14 1008- 12 14 1007- 12 14 Fibula, Distal Fibula, Proximal Fibula, Ring Fibula, Segment Fibula, Segment Specify Side (L,R) Specify Side (L,R) ≤ 5 cm 6-10 cm Fibula, Segment Fibula, Whole Humerus, Distal Humerus, Head Humerus, Proximal Humerus, Shaft Humerus, Whole Ilium, Hemi Ilium, Whole Mandible, Hemi Mandible, Whole Matchsticks, Cortical (10/pk) Matchsticks, Ilium (5/pk) Patellar Wedge Pelvis, Hemi Pericardium Radius, Ring Radius, Segment Radius, Distal Radius, Proximal Rib Rib Talus 11+ cm 1006- 12 14 Specify Side (L,R) FIBULA Specify Side (L,R) 114814 Specify Side (L,R) 114914 Specify Side (L,R) HUMERUS-PROX 1152- 12 14 Specify Side (L,R) 115314 Specify Side (L,R) 1154- 12 14 115214 Specify Side (L,R) 1159- 12 14 116114 0.5 x 5.0 cm 1260- 12 0.5 x 5.0 cm 1011- 12 1167- 12 14 Specify Side (L,R) 116814 1259- 12 1173- 12 1174- 12 14 Specify Side (L,R) 117114 Specify Side (L,R) 117214 1.0-6.0 cm 1176- 12 14 > 6 cm 1177- 12 14 Specify Side (L,R) 117914 FD= Freeze Dried / FR= Frozen Orthopaedic Spine Trauma Citagenix.com 5 Reconstructive Allografts Description Size/Side Tibia, Shaft Split (1) Tibia, Distal Specify Side (L,R) Tibia, Shaft Tibia, Proximal w/Tuberosity Specify Side (L,R) Tibia, Proximal w/Pat. Ligament Specify Side (L,R) Product code FD FR 1187- 12 14 118014 1185- 12 14 TIBIA-PROX 118114 Tibia, Whole Ulna, Ring Ulna, Segment Ulna, Proximal Ulna, Distal Ulna, Whole 118814 1193- 12 14 1194- 12 14 119214 119114 119514 Specify Side (L,R) FD= Freeze Dried / FR= Frozen Description Size/Side Product code Tri-Cortical Block Tri-Cortical Block Tri-Cortical Block Tri-Cortical Block Tri-Cortical Block Tri-Cortical Block Tri-Cortical Block Width ≤ 1.0 cm Width 1.1-1.4 cm Width 1.5-1.9 cm Width 2.0-2.9 cm Width 3.0-3.9 cm Width 4.0-4.9 cm Width 5.0+ cm tcb10 tcb11 tcb15 tcb20 tcb30 tcb40 tcb50 Preservation: Freeze Dried Description Size/Side Costal Cartilage Costal Cartilage Length ≤ 5 cm Saline Length 5-8 cm Saline Orthopaedic 6 Preservation Spine Product code COSTAL COSTAL-L Trauma 1 877-243-6724 T2 T1 Illium Tricortical Block Sports Medicine Description Size Preservation Code Achilles Tendon with Bone Frozen achilles Achilles Tendon w/o Bone Frozen 1085-14 Achilles w/Bone, shaped 10 mm Frozen 1517-14 Achilles w/Bone, shaped 11 mm Frozen 1518-14 Gracilis Tendon Frozen gracilis Patellar Ligament, Bisected Frozen 1012-14 Patellar Ligament, Whole Frozen PATELLA Patellar w/Extensor Mechanism Frozen 1162-14 Patellar Ligament w/Quad, Whole Frozen 1013-14 Patellar, shaped 10 mm Frozen 1473-14 Patellar, shaped 11 mm Frozen 1502-14 Peroneus Tendon Frozen peroneus Semitendinosus Tendon Frozen semi-t Semitendinosus/Gracilis (2/pk) Frozen 1501-14 Tibialis Tendon, Anterior Frozen atib Tibialis Tendon, Posterior Frozen ptib Orthopaedic Citagenix.com 7 Demineralized Bone Matrix (DBM) products A wide variety of grafting options for a wide variety of cases The proven clinical success of Citagenix DBM Products in multiple forms gives clinicians the ideal bone graft for the specific application. Accell Connexus® - Bone grafting naturally Accell Connexus contains Accell Bone Matrix (ABM). DBM RPM ABM This patented, dispersed form of DBM offers significantly increased surface area, which provides access to natural bone proteins. Analysis shows that while ABM provides early access to natural bone proteins, particulate DBM provides access to these proteins at later time points. Bone graft substitutes Differentiating technology DBM Particulate Demineralized Bone Matrix (DBM) consists of a highly dense matrix of Type-I Collagen and naturally occurring growth factors, with limited accessibility. RPM Our DBM products incorporate a poloxamer Reverse Phase Medium (RPM), a highly biocompatible carrier. This unique thermoreversible carrier allows these products to meet the needs of challenging surgical applications where robust handling is essential. ABM Accell Bone Matrix (ABM) consists of an open pore structure with high surface area. The resultant scaffold provides accessibility to bone proteins, which creates a favorable environment for the formation of bone. 8 OrthoBlast® II - DBM with cancellous bone Combining osteoinductive and osteoconductive elements in a proprietary, reverse phase medium, OrthoBlast® II is a powerful choice for bone grafting. The cancellous bone found in OrthoBlast DBM RPM CANCELLOUS II offers an osteoconductive scaffold facilitating the attachment of osteogenic precursor cells. DynaGraft® II - Easy to use bone graft substitute DynaGraft® II is a unique bone graft substitute composed of demineralized bone matrix (DBM) in a poloxamer reverse phase medium. Used either alone or as a bone graft extender, it helps promote successful surgical outcomes. DBM RPM Electron beam sterilization · Validated Osteoinductive Potential Inert, biocompatible and safe · Superior Handling Thickens at body temperature · Resists irrigation Store at room temperature · Moldable and easy to pack e, imag ucts w d Ne ro ep sam Demineralized Bone Matrix (DBM) Description Size Demineralized Bone Matrix Accell Connexus 1 cc Product code Accell Connexus 2.5 cc 02-3000-025 Accell Connexus 5 cc 02-3000-050 Accell Connexus 10 cc 02-3000-100 Dynagraft II Putty 1 cc 02-2010-010 Dynagraft II Putty 2.5 cc 02-2010-025 Dynagraft II Putty 5 cc 02-2010-050 Dynagraft II Putty 10 cc 02-2010-100 Dynagraft II Gel 5 cc 02-2000-050 Dynagraft II Gel 10 cc 02-2000-100 OrthoBlast II Putty 5 cc 02-2110-050 OrthoBlast II Putty 10 cc 02-2110-100 OrthoBlast II Paste 1 cc 02-2100-010 OrthoBlast II Paste 3 cc 02-2100-030 OrthoBlast II Paste 8 cc 02-2100-080 Orthopaedic 02-3000-010 Spine Plastic & Reconstructive Citagenix.com 9 Synthetic bone graft cement ne w Moldable & Injectable Bone Substitute Material Gamma-bsm — moldable bone substitute material ETEX’s Gamma-bsm moldable putty meets the need for hard setting, high compressive strength materials that are implantable in a wet environment. Gamma-bsm is engineered using ETEX’s proprietary nanocrystalline calcium phosphate technology and undergoes cell-mediated remodeling. Beta-bsm — injectable bone substitute material Beta-bsm addresses the need for high strength materials delivered in minimally invasive procedures. Beta-bsm is engineered using ETEX’s proprietary nanocrystalline calcium phosphate technology, is mixed in a closed syringe to syringe system and can be delivered through as small as a 20 g needle. Description Gamma-bsm Code 1 cc kit 76-6001 2.5 cc kit 76-6023 5 cc kit 76-6005 10 cc kit 76-6010 Beta-bsm 2.5 cc kit 76-6025 5 cc kit 76-6016 10 cc kit 76-6017 gamma-bsm · Sets Hard · High Strengt · Cell-Mediated Remodeling beta-bsm · MIS Centric · High Strength · Cell-Mediated Remodeling ETEX nanocrystalline calcium phosphate mimics the mineral composition of human bone, providing an ideal scaffold for new bone growth. 10 Synthetic Grafts Performance Criteria CRITERIA FEATURES CLINICAL BENEFITS Gamma-bsm Beta-bsm Gamma-bsm Beta-bsm Mixing Open mixing system Patent pending syringe to syringe User friendly / mix with blood or saline User friendly closed mixing system Formulation Proprietary Nanocrystalline Calcium Phosphate Proprietary Nanocrystalline Calcium Mimics chemical structure of human Phosphate bone to facilitate remodeling Mimics chemical structure of human bone to facilitate remodeling Handling Moldable putty Injectable through 20 g needle for orthopedic applications / 16 g needle Easily packed into open defects included Minimally invasive delivery Cohesive Sets in a wet environment, may be irrigated after setting Sets hard in a wet environment, may Complete defect fill / resists wash out be irrigated after setting Complete defect fill / resists wash out Structure Sets hard and maintains shape Sets hard and maintains shape Continuous osteoconductive scaffold Continuous osteoconductive scaffold Working Time 15 minutes 2 minutes Intra-operative flexibility Intra-operative flexibility Setting time Isothermically sets in 3-5 minutes at 37°C Isothermically sets in 3-5 minutes at 37˚C Sets hard upon closure / no damaging heat release Sets hard after closure / no damaging heat release Compressive Strength Average of 46 MPa Average of 30 MPa Strength four times cancellous bone Strength three times cancellous bone Drillability Drillable during and after setting Drillable during and after setting Procedural flexibility Procedural flexibility Remodeling Cell mediated remodeling Cell mediated remodeling Remodels at the rate of new bone growth Remodels at the rate of new bone growth Sizes 1 cc, 2.5 cc, 5 cc and 10 cc 2.5 cc, 5 cc and 10 cc Accommodates a variety of indications Accommodates a variety of indications Natural Bone (X-ray diffraction) ETEX BSM (X-ray diffraction) Manufactured by Etex Corporation Orthopaedic Trauma Plastic & Reconstructive Citagenix.com 11 Synthetic bone graft cement ne A new generation in Self Hardening Bone Void Filler w Macrofix™ — Self Hardening Bone Void Filler Macrofix™ is composed of porous Biphasic Calcium Phosphate granules in an amorphous Biphasic matrix. The material can be packed or injected into the defect and is suitable to be used in conjunction with any plating system. Macrofix is fully set up in 20 minutes, and by 24 hours equals the compressive strength (10-12 MPa) of host trabecular bone. Post implantation, remodeling occurs through the controlled dissolution of the matrix allowing revascularization, entrapment of growth factors, and proliferation of osseous tissue throughout the osteoconductive BCP granules. Mix Implant Set time Initial mechanical strength Macrofix™ features & benefits: • Injectable - Ideal for minimally invasive procedures • Handling - Stays put in surgical site and resists irrigation • Moldable - Fills complex bone defects • Robust - Self hardens with optimum working time • Absorbable - New bone at the expense of the Macrofix matrix Macrofix rapidly integrates into the bone structure Immediate section after Macrofix filling of rabbit femoral epiphysis defect. 12 12 weeks after implantation - Interconnected lamellar bone trabeculae formed after Macrofix resorption (grey) Bone marrow (black) and residual BCP granule (white). Synthetic Grafts Description MBCP Granules Size Code 1-2 mm 2 cc 2G020 1-2 mm 10 cc 2G100 2-3 mm 10 cc 3G100 2-3 mm 30 cc 3G300 1 cm by 4 1ST04 2 cm by 4 2ST04 5 mm base by 1 SW05 6 mm base by 1 SW06 8 mm base by 1 SW08 10 mm base by 1 SW10 12 mm base by 1 SW12 MBCP Sticks MBCP Square Wedges MacroFix (Injectable Self Hardening Bone Void Filler) Syringe 3 cc MACROFIX3 Syringe 5 cc MACROFIX5 Syringe 10 cc MACROFIX10 Orthopaedic Spine Trauma Citagenix.com Plastic & Reconstructive 13 ™ ne INTEGR A MOZAIK OSTEOCONDUCTIVE SCAFFOLD w Clinically Proven — Integra Mozaik Osteoconductive Scaffold has been shown to be equally effective to autograft A key clinical study on the use of the Integra Mozaik matrix (versus autograft) in posterolateral lumbar fusion supports the product’s safety and effectiveness as an alternative to autograft. Clinical Performance Fusion rates were equivalent to autograft, including the ability to achieve fusion in 100% of one and two level procedures. Single Level Two Level Three Level Four Level 0 20 40 60 80 100 • Equivalent performance between the Integra Mozaik scaffold and autograft • Success in a patient population containing many common confounding factors or comorbidities including smoking, diabetes, and osteoporosis • In cases of successful fusion, definitive, uninterrupted bridging of well mineralized trabecular bone was observed 12 months after surgery, as determined by an independent radiologist blinded to treatment • Integra Mozaik scaffold applied as indicated with bone marrow aspirate alone, no addition of autograft or allograft • Spinal fusion comparisons performed in each patient individually, Integra Mozaik scaffold applied to the symptomatic side and autograft to the contralateral side Representative radiographs from the referenced study. CT-scans from two patients at 12 months post-op. 14 90% Overall Fusion Synthetic Grafts Clinically Proven – Integra Mozaik™ Osteoconductive Scaffold has demonstrated equivalent fusion performance to autograft in a retrospective study on posterolateral lumbar fusion that included patients with many common comorbidities such as smoking, diabetes, and osteoporosis. This clinical study found 100% fusion in all single and two-level procedures, with an overall fusion rate of 90%. Diverse Configurations – The Integra Mozaik scaffold is offered in three diverse configurations including strip, putty, and moldable morsels to meet varying application needs and preferences. Each configuration benefits from purified components and advanced engineering while offering unique advantages to the surgeon. Compression Resistance – The formulation of β-TCP and cross-linked Type-I collagen in Integra Mozaik strip provides the material with structure and compression resistance. Integra Mozaik strip maintains its graft placement and three-dimensional structure while allowing for surgical flexibility in various applications. Carrier for Cells and Proteins – The Integra Mozaik matrix has an interconnected pore structure that absorbs bone marrow aspirate, which contains cells and proteins that play an important role in bone formation. Integra’s collagen technology enhances the binding of bone forming proteins and cells. Advanced Engineering – The blend of 20% Type I Collagen and 80% highly purified β-TCP in the Integra Mozaik scaffold provides an exceptional osteoconductive scaffold for bone regeneration. The specialized architecture is engineered to resemble the porosity of natural human bone, and promotes successful fusion. Radiographic Visualization – The β-TCP used in the Integra Mozaik scaffold provides radiographic visualization of graft placement, and acts as an indicator of active resorption during healing. Exceptional Resorption Profile – The β-TCP component of the Integra Mozaik matrix is engineered to resorb at a rate consistent with the formation of new bone. The residence time allows for the complete replacement of the graft material by new natural bone. Integra Engineered Collagen Matrix – With 30 years of experience in regenerative technology and over 10 million implants to date of products such as DuraGen® Dural Graft Matrix, Integra’s engineered collagen matrix carries a long history of safe and effective use. Moldable Putty Orthopaedic Compression Resistant Strip Description Catalog Number Description Catalog Number 15 cc PTY10256 15 cc (100 x 25 x 6mm) CCM10256 10 cc PTY10210 10 cc (100 x 25 x 4mm) CCM10210 5 cc PTY10155 2.5 cc PTY10125 Spine Trauma Citagenix.com 15 OR Equipment The Osteodisc® will grind your harvested autogenous or allograft bone into usable particles. The Osteodisc, with its innovative and ergonomic design, consists of a stainless steel bell shaped body with drive shaft and a disposable disc shaped blade with locking key. The Osteodisc’s drive shaft fits power sources commonly found in the OR. Main unit dimensions: 133 mm (h), 100 mm (w) Total interior volume: 420 cc Total weight: 1.9 kg Drive shafts and single use disc blades sold separately • Easy to assemble and easy to use • Grinds allograft and autogenous bone • Single use disc blade guarantees sharp cutting edges • Grinds bone to 1-2 mm particles • Fits commonly used OR power source Description Osteodisc Code Bone Mill ODOKIT Disc blade ODOBLADE Orthopaedic 16 Actual size Spine 1 877-243-6724 Fall 2014 Orthopaedic Catalogue GP-2004.6 (10/2014)
